Psychological Treatment for Paraphilic Disorders

ConditionParaphilic Disorders

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorRegion Stockholm

About this trial

The goal of this randomized study is to learn if a psychological intervention can treat help-seeking patients with paraphilic disorders.

The main questions it aims to answer are:

1. Is psychological therapy helpful for the reduction of problematic sexual behaviors among patients with paraphilic disorders? 2. Is psychological helpful for the reduction of psychiatric symptoms and risk factors for sexual violence and improving quality of life among patients with paraphilic disorders? 3. How do patients with paraphilic disorders describe pathways to care (e.g. perceived obstacles to seeking care) and how do they experience the treatment?

The treatment addresses specific sexual problems. It also addresses mental symptoms (e.g. depression and anxiety). A psychologist provides the treatment face to face (on site or video). The aim is to finish the treatment within 12 weeks.

The patient will report symptoms on a daily basis. The patient will also be interviewed after completion of treatment. The investigator will pose questions such as "Was there anything that was experienced as particularly helpful in the treatment?", "Was there anything that was not helpful?". The investigator will also ask about treatment seeking behavior with questions such as "What kinds of resources would be helpful if they were available?"

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants included in the study Paraphilic Disorders and Other Conditions With Risk for Sexual Violence: a Case-control Study

Deemed to benefit from CBT.

Signed informed consent form for participation in the CBT treatment.

Disqualifiers

Mental condition that could negatively influence either the patient's health or the scientific aspects of the study, e.g., substance use syndrome, other ongoing psychotherapeutic treatment.

Initiation of medication or change change of concurrent medication or dosage in the past three months regarding antidepressants, attention deficit hyperactivity disorder medication, cortisone, testosterone, naltrexone, testosterone blockers, or dopamine precursors. Smaller adjustments may in some cases be acceptable (assessed by study psychiatrist).

Trial design

Design model

Single group

Treatments tested in this trial

Cognitive behavioral therapy (CBT)
Behavioral
se above

Treatment groups

14 Participants

are divided into 1 treatment group

Group A: Cognitive behavioral therapy (CBT)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Questions about sexual behaviors ("diary")

Three questions about time spent on problematic sexual behaviors or fantasies, level of desire and sex as coping. Each question is scored 0-4. The main outcome measure is the total score of these three questions (0-12 points). A higher score indicates more severe problems.

Time frame

From date of randomization until the date of end of treatment (week 12), and a follow-up assessement 3 months after end of treatment.

Questions about sexual behaviors ("diary")

Three questions about time spent on problematic sexual behaviors or fantasies, level of desire and sex as coping. Each question is scored 0-4. The three problem areas described under main outcome are handled as separate items and analyzed separately. A higher score indicates more severe problems.

Time frame

From date of randomization until the date of end of treatment (week 12), and a follow-up assessement 3 months after end of treatment.

Frotteuristic Disorder:Current Assessment Scale (FD: CAS)

The questionnaire will be used if the participant has a diagnosis of frotteuristic disorder. The questionnaire assesses frotteuristic behaviors. The questionnaire is scored 0-32. A higher score indicates more severe problems.

Time frame

start of randomization (phase A), start of treatment (phase B), in the middle of treatment (week 6), at end of treatment (week 12), and follow-up 3 months after treatment.

Voyeuristic Disorder: Current Assessment Scale (VD: CAS)

The questionnaire will be used if the participant has a diagnosis of voyeuristic disorder. The questionnaire assesses voyeuristic behaviors. The questionnaire is scored 0-32. A higher score indicates more severe problems.

Time frame

start of randomization (phase A), start of treatment (phase B), in the middle of treatment (week 6), at end of treatment (week 12), and follow-up 3 months after treatment.

Secondary outcomes

A question about general well-being

A question from general well-being schedule, scored 0-6. A higher score indicates more severe problems.

Time frame

From date of randomization until the date of end of treatment (week 12), and a follow-up assessement 3 months after end of treatment.

The Brief version of the Difficulties in emotional regulation scale (DERS-16)

Score range is 16-80. A higher score indicates more severe problems.

Time frame

start of randomization (phase A), start of treatment (phase B), in the middle of treatment (week 6), at end of treatment (week 12), and follow-up 3 months after treatment.

Brunnsviken Brief Quality of Life Inventory (BBQ)

Score range is 0-48. A higher score indicates high quality of life

Time frame

start of randomization (phase A), start of treatment (phase B), in the middle of treatment (week 6), at end of treatment (week 12), and follow-up 3 months after treatment.

Perceived Social Support (PSS-14)

Two subscales, one addressing support from family and the other from friends. Score range is 20-80. A higher score indicates more severe problems.

Time frame

start of randomization (phase A), start of treatment (phase B), in the middle of treatment (week 6), at end of treatment (week 12), and follow-up 3 months after treatment.

Other outcomes

Qualitative interview (research question c)

A 60 min interview questions such as "Can you tell us about the treatment you received", "What do you take with you from the treatment?", "Was there anything that you experienced as particularly helpful in the treatment?", "Was there anything that was not helpful?"

Time frame

After completion of treatment (week 12)

Quality assurance of the manual after each module

Include questions such as "how relevant and helpful did you find the current module on a scale of 1-5 (1 = not at all helpful, 3 = neither, 5 = very helpful), How much time did you spend working on the material (reading and doing homework)?

Time frame

After each treatment module (i.e., 10 times under a time-period of 12 weeks)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Region Stockholm

Lead sponsor

Source ClinicalTrials.gov

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